Anvisa opens public consultation on digital package leaflets

Brazil’s National Health Surveillance Agency (Anvisa) will hold a public consultation (CP 1.224/2023) between 20 December 2023 and 19 March 2024 to regulate digital package leaflets for medicines. Provided for in Law 14.338 sanctioned on 12 May 2022, known as the Digital Package Leaflet Law, the initiative paves the way for dispensing with printed leaflets on the packaging of certain medicines in the future.

The law guarantees laboratories the possibility of inserting a two-dimensional barcode (QR Code) into the packaging of medicines for quick reading of information on composition, usefulness, dosages and contraindications. It will also direct the interested party to the medicine’s digital package leaflet and provide access to more information, such as videos and other instructions that help with the proper use of the medicine.

The Digital Package Leaflet Law was created by amending Law No. 11,903 of 2009 and provides for the creation of the federal government’s National Medicines Control System, whose purpose is to monitor medicines throughout the production chain, from manufacture to consumption by the population.

It is stipulated that the digital package leaflets must be hosted on websites authorised by the competent federal health surveillance authority, and the respective laboratories will be able to insert information in addition to the complete and up-to-date content identical to that of the printed package leaflet. The format must be easy to read and understand and allow the text to be converted into audio and/or video using an appropriate application. Laboratories will also have to maintain a system for drawing up drug distribution maps to identify batches and recipients of drug shipments. The law establishes a period of 12 months after the regulation of the system for the implementation of the systems.

According to the text of the law, the printed package leaflet is still required and cannot be dispensed with, except in cases to be defined by Anvisa.

To take part in the public consultation, you need to read the proposal with the guidelines for implementing digital package leaflets. After reading the proposal, you need to fill in a form with identification fields and send in your contributions. At the end of the period of suggestions, Anvisa will evaluate them and publish an analysis report on its website.

In Europe

The European Commission leaves it up to each country to decide whether the package leaflet will be in electronic or paper format, or both.

Currently, instructions on medicines, including dosage, storage or side effects, are provided by means of a package leaflet in the packaging of the medicine, but a reformulation of the regulatory framework presented by the European Commission on 26 April 2023 for pharmaceutical products gives the option of retaining, in principle, the electronic format of the leaflet.

However, it will be necessary to guarantee a paper version of the package leaflet on request and at no extra cost to those interested, and also that the information in digital format is easily accessible to all, for example by means of a digitally readable code on the outside of the product packaging that directs to the electronic version of the leaflet.

In search of a standard

According to the Organisation for Economic Co-operation and Development (OECD), around 200,000 premature deaths occur every year in Europe due to poor adherence to medication, a situation that can cost up to €125 billion a year in avoidable hospitalisations, emergency care and outpatient visits for adults.

One way to help alleviate this scenario is through a standard for electronic drug information (ePI). In general, electronic data on medicines is presented in PDF files, so having an official, structured format for package leaflets and characteristics of pharmaceutical products using structured data would assist in the accurate publication of this information among various groups, from patients to healthcare professionals.

Created by the HL7 organisation, the FHIR (Fast Healthcare Interoperability Resources) standard is designed to facilitate the modelling and interoperability of healthcare data, including medicines. It offers different developer communities an easy-to-adopt structure based on standards that are familiar even to non-healthcare professionals.

Datapharm, a provider of medical information platforms, has been instrumental in developing a new ePI standard for medicines, working with the main pharmaceutical and medical information organisations in Europe.